Kornimate/medical-research-clean huggingface dataset:
phase 2 study to examine grape seed extract as an anti-oligomerization agent in alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: alzheimer disease (ad) is a progressive brain disease generally known as senile dementia. our proposed study will establish safety and pharmacokinetics of meganatural-az gspe in ad subjects. as secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of gspe in mitigating cognitive deterioration in ad patients.

this study aims to establish the safety and pharmacokinetics of meganatural-az® gspe in subjects with alzheimer's disease. as a secondary goal, clinical and biomarker indices of therapeutic efficacy will also be evaluated. the proposed study will provide the essential human data necessary to guide the design of future studies testing the efficacy of gspe in mitigating cognitive deterioration in ad patients.

Eligibility criteria:
inclusion criteria: * nincds/adrda criteria for probable ad * mmse between 12-26 * treatment with a cholinesterase inhibitor or an nmda (n-methyl-d-asparate) antagonist with stable dose for at least 12 weeks * home monitoring available for supervision of medications * caregiver available to accompany patient to all visits and willing to participate in study as informant * fluent in english or spanish * medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests * stable doses of non-excluded medication * no evidence of hepatic insufficiency * able to swallow oral medications * ability to participate in the informed consent process exclusion criteria: * history of hypotension or unstable hypertension * active hepatic or renal disease * use of another investigational drug within the past two months * history of clinically significant stroke * history of seizure or head trauma with disturbance of consciousness within the past two years * major mental illness including psychotic disorders, bipolar disorder, or major depressive episode that is not in remission for less than 12 months * women of child-bearing age unless using effective birth control or at least one year post-menopausal or surgically menopausal * any ferrous or metallic materials which are contraindicated for mri medication exclusions * current use of drugs with significant anticholinergic or antihistaminic properties

Keywords: alzheimer's disease grapeseed extract clinical trial meganatural-az anti-oligomerization phase 2 dietary supplement nutraceutical
core-compare pilot study

Conditions: Coronary Heart Disease (CHD)

Summary: the utility of ultra high-resolution computed tomography (uhr-ct) compared to conventional ct in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with uhr-ct, as well as longer scan times. the availability of technology to reconstruct conventional resolution (cr) simulation images from the raw ct acquisition data acquired on the uhr-ct scanner offers a unique platform to study this question without subjecting individuals to two different scans. the primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive uhr-ct is superior to conventional resolution ct for identifying patients with obstructive chd.


Eligibility criteria:
inclusion criteria: * patients aged 21-85 years * clinical history suggestive of chd who are referred by their primary cardiologist for further evaluation via computed tomography angiography (cta) will be asked to participate. * women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study cta. * ability to understand and willingness to sign the informed consent form. exclusion criteria: * known allergy to iodinated contrast media. * history of multiple myeloma or previous organ transplantation * elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the cockcroft-gault formula * atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) * evidence of severe symptomatic heart failure (nyha class iii or iv); * known or suspected moderate or severe aortic stenosis * history of prior percutaneous coronary intervention (pci) in one or more vessel or history of coronary arterial bypass grafting (cabg) * suspected acute coronary syndrome * presence of any other history or condition that the investigator feels would be problematic
safety and efficacy of autologous mesenchymal stem cells in chronic spinal cord injury

Conditions: Spinal Cord Injury

Summary: this phase ii/iii clinical trial is designed to evaluate the safety and efficacy of autologous mesenchymal stem cells (msc) transplanted directly into the injured spinal cord.

the principal investigator has performed a clinical trial using autologous mscs in patients with cervical spinal cord injury. the results revealed the safety of autologous msc. this phase ii, iii single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. after recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.

Eligibility criteria:
inclusion criteria: * aged between 16-65 years * traumatic spinal cord injury at the level of cervical * american spinal injury association impairment scale b * 12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy * no signs of contracture * good physical condition to go through operation * must be willing and able to participate in study procedures with no mental and verbal problem * able to consent by patients or legal representatives exclusion criteria: * serum sgot/sgpt \> 3 x upper limit of normal or creatinine \> 1.5 x upper limit of normal * major surgical procedure in the past 3 months * penetrating injury * mechanical ventilation * serious pre-existing medical conditions * recently diagnosed infection (urinary tract infection, pneumonia etc) * positive skin test for penicillin * positive result for viral markers (human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) and venereal disease research laboratory (vdrl) test) * pregnant women, women of childbearing potential who do not want adequate contraception, breastfeeding females * unwilling to participate in study * patients with psychiatric disorder severe as to make compliance with the treatment unlike, and signing informed consent impossible * drug abuse in the past 1 year * participating in other clinical trials in the past 1 month * inappropriate patients to participate in the study according to the chief investigator

Keywords: spinal cord injury mesenchymal stem cell
nasospore stent for use in enodscopic sinus surgery

Conditions: Chronic Sinusitis

Summary: the purpose of this study is to evaluate a stenting material called nasopore. this is a synthetic material approved by fda for use as a stent in postoperative sinus surgery patients. this study will compare the nasopore stent to other approved stenting materials.

this study will compare other sinus stenting products to the nasopore stent. the stents will be soaked in antibiotic solutions and be observed for how well they perform. subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.

Eligibility criteria:
inclusion criteria: * evaluation by otolaryngologist \& determined to need endoscopic sinus surgery * only subjects with bilateral disease exclusion criteria: * pediatric subjects(under the age of 18)
study on the effectiveness of egb 761® vs placebo used for cognitive impairment in patients with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine whether the use of egb 761 by patients with relapsing-remitting multiple sclerosis is effective in improving cognition, when compared to placebo.


Eligibility criteria:
inclusion criteria: * patient with multiple sclerosis relapsing-remitting form * patient with cognitive impairment (as spontaneous complaint by either patient or family) * patient treated with interferon and maintaining same dosage for previous 6 months * patient without major disability (kurtzke extended disability status scale ≤6) exclusion criteria: * clinical multiple sclerosis relapse within 3 months prior to participation * major psychiatric disease according to diagnostic and statistical manual of mental disorders, 4th ed. * other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)

Keywords: cognitive impairment
validating the use of frailty measurements to predict care & quality of life

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians. this work will provide a foundation in the development of customized interventions for people with copd and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers.


Eligibility criteria:
inclusion criteria: * outpatients of the ottawa hospital respirology clinic * chronic obstructive pulmonary disease diagnosis confirmed by pulmonary function testing. * english or french speaking exclusion criteria: * patients with a known diagnosis of severe cognitive impairment

Keywords: frailty care expectations
a study to explore prognoses of nsclc patients complicated with oligometastases

Conditions: Non Small Cell Lung Cancer

Summary: an observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases

a multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases

Eligibility criteria:
inclusion criteria: * pathologically diagnosed patients with non-small cell lung cancer; * tumor metastases in one organ (no more than 3 metastases); exclusion criteria: * patients with intrapulmonary metastases or multiple primary tumors; * patients with pleural dissemination or invasion of extrapulmonary organs; * patients with supraclavicular lymph node metastasis; * patients with systematic diseases that would influence patient survivals; * patients with no records for visits;

Keywords: chinese non-small cell lung cancer oligometastases
autonomic involvement in patient with cognitive decline

Conditions: Dementia, Mild; Dementia of Alzheimer Type

Summary: prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline


Eligibility criteria:
inclusion criteria: * male and females between 50 and 85 years * cognitive decline (dementia, lewy's body dementia, parkinson dementia, alzheimer dementia) * mild cognitive decline ( lewy's body mci, parkinson mci and alzheimer mci) * ability to assume the upright position exclusion criteria: * diabetes mellitus * eye problems * severe cognitive decline * heart disease * peripheral neuropathy * language barrier * oncological disease * medical pathologies associated with cognitive deficits
leipzig adipose tissue childhood cohort

Conditions: Childhood Obesity; Insulin Resistance

Summary: in this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. the investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.

the investigators aim to identify how adipose tissue dysfunction in childhood contributes to the development of obesity and related comorbidities and to characterize factors that play a role in the development of adipose dysfunction in children. the investigators will employ a translational approach which is based on the characterization of adipose tissue biology in samples of children to determine alterations leading to adipose tissue dysfunction. these include assessment of the composition (including bat), remodeling, function, metabolism and inflammation of adipose tissue as well as the adipokine profile. for the assessment of clinical relevance, these experimental data will then be correlated with the clinical phenotype. finally, we aim to identify factors responsible for early adipose tissue dysfunction and characterize them for their clinical and functional relevance.

Eligibility criteria:
inclusion criteria: * body weight: 3000 g - 180 kg * suitable surgical procedure * signed informed consent by the guardians and the study participant, if older 12 years exclusion criteria: * severe chronic and inflammatory diseases * acute or chronic infections * oncological diseases * clotting disorders * complications during surgical procedure * drug treatment * nil by mouth

Keywords: children obesity adipose tissue dysfunction inflammation macrophage infiltration insulin resistance dyslipidemia
percutaneous endoscopic gastrostomy tube placement by otorhinolaryngologist

Conditions: Dysphagia

Summary: the investigators main endpoint was focused on the analysis of the type, rate and the impact of different clinical parameters on the complications of the peg tube placements performed at the department of otorhinolaryngology - head and neck surgery since october 2008. in addition, the investigators aimed to compare the results with a historic cohort patient group (september 2005 - october 2008) sent to the department of surgery for peg tube placement in order to evaluate the results of the changed routine.

we retrospectively reviewed a cohort of patients that had undergone peg tube placement from october 2008 until october 2010 at the department of otorhinolaryngology - head and neck surgery, helsinki university central hospital (huch), helsinki, finland, with a health care district currently including approximately 1.5 million inhabitants. hospital surgical and discharge registries were used to identify the patients. medical records were studied and details collected on the patients' age, sex, preoperative condition, preoperative laboratory parameters, coexisting medical diagnoses (charlson comorbidity index, cci (hall 2004)), indication and date for peg tube placement, complications, the time of peg use, follow-up time, and clinical status at last follow up. the study period was aimed to run from peg tube placement to the last clinical evaluation (minimum 12 months) or the time of death. these results were compared with those from a historic cohort group of patients with the peg tube placed in the department of surgery, huch, helsinki, finland from september 2005 until october 2008.

Eligibility criteria:
inclusion criteria: * ent patient with peg tube placement exclusion criteria: * electrolyte imbalance * coagulation imbalance * morbid obesity (bmi \> 40 kg/m2) * large volume ascites * previous gastrectomy * sepsis
polyphenols and insulin resistance

Conditions: Healthy Volunteers; Insulin Resistance; Type 2 Diabetes (T2D)

Summary: diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (t2d) and associated cardiovascular complications. the main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. for that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and t2d (1st degree relatives of t2d patients with associated overweight). these volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. the demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.


Eligibility criteria:
inclusion criteria: * absence of anti hiv or anti hepatitis c antibodies and of hbs antigen. * acceptable biological assessment of the hepatic and renal functions (γgt, alat, asat \< 3 times the normal value and serum creatinine \<150 micromol/l). * age between 30 and 55 years. * fasting plasma glucose \<110 mg/dl and absence of any anti-diabetic treatment * no regular physical activity (voorips index \< 9) * absence of any drug treatment in progress and during the last 2 months * subjects with at least one 1st degree relative with t2d and with a body mass index between 25 and 35 kg/m² and a waist measurement \>94 cm for males, and \>80 cm for females. * normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l). * normal ferritin level (75 - 300 ng/ml) * hs-crp \<8 mg/l. * absence of arterial hypertension (systolic pressure \<140 mmhg and diastolic pressure \<90 mmhg). * non smoker or former smoker (quit smoking \>1 year). * alcohol consumption \<30 g/day. exclusion criteria: * hyperthermia (t°\>38°c) * subject deprived of freedom by a court or administrative order * major protected by the law * subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached. * subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month. * subject who cannot be subjected to muscle biopsy. * allergy to the anaesthetic * woman in age to procreate and not taking any oral or intra-uterine contraception

Keywords: insulin resistance type 2 diabetes (t2d) cardiovascular complications polyphenolic compounds derived from red grape marc extracts oxidative stress
18f-fluciclovine pet-mri in high-grade glioma

Conditions: Glioma; High Grade Glioma; Glioma, Malignant; Glioma Intracranial; Diffuse Glioma

Summary: the purpose of this study is to see if 18f-fluciclovine (axumin®) pet imaging is useful and safe in the management of children with high grade gliomas. investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

following radiation and immunotherapy, many pediatric participants with high-grade gliomas (hgg), including diffuse midline glioma (dmg), demonstrate radiographic findings suspicious of disease progression. differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. unfortunately, conventional mri cannot reliably distinguish between true progression and post-treatment changes. therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical. the overall objective of this current application is to evaluate 18f-fluciclovine pet imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric hgg. the long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric hgg using 18f-fluciclovine pet imaging.

Eligibility criteria:
inclusion criteria * 1. histopathology-proven hgg (who grade iii-iv) or dmg (who grade iv) or, in the case of dmg of the pons, imaging that is characteristic of diffuse intrinsic pontine gliomas (dipg) (diffusely infiltrating \&gt;=2/3 of the pons). * 2. measurable disease, measuring at least 1x1 cm. * 3. life expectancy of greater than 8 weeks. * 4. age \&gt; 1 years but \&lt; 21 years of age at enrollment. for those without planned surgery: * 1. participants with clinical and/or radiographic suspicion of true progression (tp) or pseudoprogression (psp) during radiation but yet to have the initial post-radiation mri scan. or * 2. participants with suspicion for tp or psp on first post-radiation mri for those with planned surgery: * 1. clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy. exclusion criteria: * 1. inability to tolerate imaging procedures in the opinion of an investigator or treating physician. * 2. pregnant or breastfeeding participants. * 3. participant who would require sedation or anesthesia for imaging beyond standard of care (soc). * 4. participants who weigh less than 8 kg. * 5. participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. * 6. participants with a history of abnormal kidney function or creatinine \&gt;= ctcae v5.0 grade 2 at time of study registration. 7. participants with primary tumors of the spinal cord.

Keywords: glioma high grade glioma glioma, malignant glioma intracranial diffuse glioma 18f fluciclovine